Transcatheter aortic valve replacement noninferior to surgery for intermediate-risk patients: The SURTAVI trial

1. Among patients at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) was shown to be noninferior to surgery with respect to the primary end point of death or disabling stroke at 24 months.

2. Patients who underwent surgery had higher rates of acute kidney injury, atrial fibrillation, and transfusion, whereas patients who underwent TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation.

Evidence Rating Level: 1 (Excellent)

Study Rundown: TAVR has previously been shown to be superior to medical therapy for severe aortic stenosis (AS) among patients at prohibitively high surgical risk; however, the efficacy of TAVR has not been as well characterized among patients at intermediate surgical risk.

In this study, among 1746 patients that underwent randomization, 864 underwent TAVR and 786 underwent surgery. The primary end point of the study was the composite of death and disabling stroke. For this primary endpoint, nonsignificant differences were observed between the TAVR and surgery groups at 30 days, 12 months, and 24 months. In terms of procedure-related complications at 30 days, surgery was associated with significantly higher rates of red cell transfusion, acute kidney injury, cardiogenic shock, and atrial fibrillation, while TAVR was associated with significantly higher risk of major vascular complications and need for permanent pacemaker implantation.

Click to read the study in NEJM

Relevant Reading: Transcatheter aortic-valve replacement with a self-expanding prosthesis

In-Depth [randomized controlled trial]: This SURTAVI trial was a multicenter, randomized, noninferiority trial comparing TAVR and surgery in patients at intermediate surgical risk with severe AS. In terms of the primary endpoint at 30 days, TAVR patients had an estimated incidence of 2.8% while surgery patients had an estimated incidence of 3.9% (95% credible interval -2.8 to 0.7). At 12 months, TAVR patients had an estimated incidence of 8.1% while surgery patients had an estimated incidence of 8.8% (95% credible interval -3.5 to 2.1). At 24 months, TAVR patients had an estimated incidence of 12.6% while surgery patients had and estimated incidence of 14.0% (95% credible interval -5.2 to 2.3).

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